NEW YORK, July 5, 2017 /PRNewswire/ -- RDD Pharma, a leader in developing treatments for anorectal disorders, announced today the European Medicines Agency's Committee for Orphan Medicinal Products has granted orphan designation for RDD-0315, an investigational drug for the treatment of fecal incontinence in patients with spinal cord injury. The committee recognized that RDD-0315 may be of significant benefit to spinal cord injury patients affected by fecal incontinence.
"We are pleased the EMA recognized the clinically significant benefit that RDD-0315 may offer spinal cord injury patients," stated Jason Laufer, Chief Executive Officer, RDD Pharma. 'We have the potential to positively impact the health, well-being and quality of life in this patient population. '
The Orphan Designation provides potential incentives from the European Union to develop a medicine with a prevalence of less than 5 in 10,000, such as protocol assistance, reduced fees, funding from the European Commission for clinical trials, and protection from competition once the medicine is placed on the market, including 10 years of market exclusivity.
Positive Phase 2a results in evaluating the safety and efficacy of RDD-0315 for the treatment of fecal incontinence in spinal cord injury patients have previously been reported with a statistically significant reduction in the number of fecal incontinence episodes at 8 and 12 hours post-administration.
"We are thrilled with the EMA's recognition of positive results seen in our Phase 2a study and the potential of a treatment such as RDD-0315 for patients who suffer from fecal incontinence," said Nir Barak, Chief Medical Officer of RDD Pharma. "We look forward to advancing our studies in the EU and to filing an IND with the US Food and Drug Administration later this year."
About RDD Pharma RDD is a privately held specialty pharma, focused on fast-track development and commercialization of innovative therapeutics for anorectal diseases and gastrointestinal disorders. RDD Pharma's lead product for the treatment of pain associated with anal fissure is currently in a Phase 3 clinical study in Europe. RDD-0315 for fecal incontinence is in the midst of Phase 2b preparations in the EU and preIND stage in the US. Products currently under development at RDD are expected to reach the market in three to six years.
About Fecal Incontinence Fecal Incontinence results from damaged or weakened anal sphincter muscles. Treatment options are very limited. It is a condition that can occur at any age and is often devastating to a person's quality of life. For older people, fecal incontinence often results in early institutionalization because family members have difficulty coping with the problem at home. Over 8% of non-institutionalized adults (~20 million) suffer from fecal incontinence in the US. The average annual direct cost of fecal incontinence in the US is estimated to be over $17,000 per person. Loss of bowel control causes embarrassment, humiliation and significantly impacts quality of life for hundreds of millions of patients globally. Currently, there are no prescription Rx therapies available for treating fecal incontinence.